Tried-and-true strategies for bringing novel drugs to market: they don’t work the way they used to. Emerging companies and drug developers need a new game plan and new resources as their pipelines mature, often choosing to go solo where previous players partnered with others. Syneos Health Executive VP Nick Marasco identifies some of the most significant changes in the launch ecosystem—and best practices to address them successfully.


In just the past five years, significant changes have occurred in how new drugs come to market. Demands for real world evidence and patient-reported outcomes are changing how and when new drugs file for approval. Accountable care organizations (ACOs), integrated delivery networks (IDNs), advocacy groups, and payers are increasingly flexing their muscles. Yesteryear’s tried-and-true paths to commercialization have developed new twists and turns, and the ecosystem has become more complicated. Here are just a few of the most important ways our world has changed:


Emerging pharma and biotech increasingly are succeeding on their own. In the past, startups with a strong asset would search for large partners or out-licensing deals. Today, however, many are looking instead for solutions that let them go it alone. Thanks to a stronger economy, there’s more capital available to them for activities beyond R&D, including funds for brand development, market conditioning, and engagements with opinion leaders. More than ever, they are prepared to invest not only in preclinical/clinical development, but also in other areas vital to launch— including key opinion leader management, negotiations with payers and stakeholders, promotion to clinicians, and even direct-to-consumer advertising in some cases.

There’s also an increasing consensus that emerging enterprises don’t always need a big, well-established pharma partner to connect effectively with stakeholder audiences. In orphan drugs and treatment-resistant cancers, for example, patient populations are often small, treatment is delivered primarily at centers of excellence, and relatively few clinicians and payers control what gets prescribed. That makes commercialization less of a large-scale enterprise.


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